(Generic versions may still be available.)
DRUG DESCRIPTION
| WARNING: Positive ANA Titer: The prolonged administration of procainamide often leads in the development of a positive anti-nuclear antibody (ANA) test, with or without symptoms of a lupus erythematosus-like syndrome. If a positive ANA titer develops, the benefits versus risks of continued procainamide therapy should be assessed. |
Procainamide hydrochloride, a Group 1A cardiac antiarrhythmic drug, is p-amino-N-[2-(diethylamino) ethyl]-benzamide monohydrochloride, molecular weight 271.79.
Procainamide Hydrochloride Extended-release Tablets meet USP Drug Release Dissolution Test 5
Procainamide Hydrochloride differs from procaine which is the p-aminobenzoyl ester of 2-(diethylamino)-ethenol. Procainamide as the free base has a pKa of 9.23; the monohydrochloride is very soluble in water. Procainamide Hydrochloride Extended-release Tablets, USP is available for oral administration as pink, scored, film-coated tablets containing 500 mg Procainamide hydrochloride, as light orange to tan, scored, film-coated tablets containing 750 mg procainamide hydrochloride, and as red scored film-coated tablets containing 1000 mg procainamide hydrochloride.
All strengths of Procainamide Hydrochloride contain calcium silicate, carnauba wax, NF; diethyl phthalate, NF; dimethyl Polysiloxane fluid; ethylcellulose, NF; hydroxypropyl methylcellulose 2910, USP; magnesium stearate NF; and vanillin, NF. The individual strengths contain additional ingredients as follows:
500 mg: D&C Red No. 30, aluminum lake; hydroxypropyl methylcellulose, USP; Polyethylene glycol, NF; polysorbate 80, NF; and titanium dioxide, USP.
750 mg: D&C Yellow No. 10, aluminum lake; FD&C Yellow. No 6, aluminum lake: hydroxypropyl methylcellulose, USP; polyethylene glycol. NF; polysorbate 80, NF; and titanium dioxide, USP.
1000 mg: FD&C Red No. 40, aluminum lake; polyethylene glycol, NF; Polysorbate 80, NF; and titanium dioxide, USP.
Procainamide Hydrochloride Extended-release Tablets contain a tablet matrix, designed for the controlled release of the drug through the gastrointestinal tract. The extended wax tablet Matrix, which is not absorbed, may be detected in the stool.
What are the possible side effects of procainamide injection (Procan SR, Procanbid, Pronestyl, Pronestyl-SR)?
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have a serious side effect such as:
- a new or a worsening irregular heartbeat pattern;
- chest pain, wheezing, trouble breathing;
- feeling like you might pass out;
- signs of infection such as fever, chills, sore throat, flu symptoms, easy bruising or bleeding...
Read All Potential Side Effects and See Pictures of Procan Sr »
What are the precautions when taking procainamide (Procan Sr)?
Before taking procainamide, tell your doctor or pharmacist if you are allergic to it; or to local anesthetics (e.g., procaine); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: certain heart problems (second- or third-degree atrioventricular block or bundle branch block unless you have a heart pacemaker), a certain immune problem (lupus).
Before using this medication, tell your doctor or pharmacist your medical history, especially of: first-degree atrioventricular block, new or recent heart attack,...
Read All Potential Precautions of Procan Sr »
Procan Sr Consumer (continued)
SIDE EFFECTS: Nausea, vomiting, loss of appetite, diarrhea, and bitter taste in the mouth may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication for a longer time may develop serious side effects, but with frequent visits to your doctor, this risk can be minimized. (See Warning section.)
Tell your doctor immediately if any of these unlikely but serious side effects occur: symptoms of liver problems (e.g., persistent nausea, stomach/abdominal pain, dark urine, yellowing eyes/skin), worsening symptoms of heart failure (e.g., ankle/leg swelling, increased tiredness, increased shortness of breath when lying down).
Seek immediate medical attention if any of these unlikely but serious side effects occur: severe dizziness, fainting, sudden change in heartbeat (unusually faster/slower/more irregular), chest pain.
Tell your doctor immediately if any of these rare but very serious side effects occur: seizures, mental/mood changes (e.g., depression, confusion, unusual thoughts/behavior, hallucinations), muscle pain/weakness, dry mouth/eyes.
A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
PRECAUTIONS: Before taking procainamide, tell your doctor or pharmacist if you are allergic to it; or to local anesthetics (e.g., procaine); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: certain heart problems (second- or third-degree atrioventricular block or bundle branch block unless you have a heart pacemaker), a certain immune problem (lupus).
Before using this medication, tell your doctor or pharmacist your medical history, especially of: first-degree atrioventricular block, new or recent heart attack, worsening chest pain (angina), low blood pressure, kidney problems, liver problems, myasthenia gravis.
Procainamide may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can infrequently result in serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that require immediate medical attention. The risk of QT prolongation may be increased if you have certain medical conditions or are taking other drugs that may affect the heart rhythm (see also Drug Interactions section). Before using procainamide, tell your doctor or pharmacist if you have any of the following conditions: certain heart problems (heart failure, slow heartbeat, QT prolongation in the EKG), family history of certain heart problems (QT prolongation in the EKG, sudden cardiac death).
Low levels of potassium or magnesium in the blood may also increase your risk of QT prolongation. This risk may increase if you use certain drugs (such as diuretics/"water pills") or if you have conditions such as severe sweating, diarrhea, or vomiting. Talk to your doctor about using procainamide safely.
Contact your doctor immediately if you develop other illnesses/conditions such as prolonged diarrhea, large quantities of diarrhea, heavy sweating, vomiting, prolonged loss of appetite, or prolonged loss of desire to drink water. These conditions could cause you to have serious changes in blood minerals, leading to increased side effects.
This drug may rarely make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.
Caution is advised when using this drug in the elderly because their bodies may not get rid of procainamide as easily, possibly leading to increased side effects.
During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.
This medication passes into breast milk and may have undesirable effects on a nursing infant. Consult your doctor before breast-feeding.
Procan Sr Patient Information Including Side Effects
Brand Names: Procan SR, Procanbid, Pronestyl, Pronestyl-SR
Generic Name: procainamide (injection) (Pronunciation: proe KANE a mide)
- What is procainamide injection (Procan Sr)?
- What are the possible side effects of procainamide injection (Procan Sr)?
- What is the most important information I should know about procainamide injection (Procan Sr)?
- What should I discuss with my healthcare provider before receiving procainamide injection (Procan Sr)?
- How is procainamide injection given (Procan Sr)?
- What happens if I miss a dose (Procan Sr)?
- What happens if I overdose (Procan Sr)?
- What should I avoid while receiving procainamide injection (Procan Sr)?
- What other drugs will affect procainamide injection (Procan Sr)?
- Where can I find more information?
What is procainamide injection (Procan Sr)?
Procainamide affects the way your heart beats.
Procainamide is used to help keep the heart beating normally in people with certain heart rhythm disorders of the ventricles (the lower chambers of the heart that allow blood to flow out of the heart).
Procainamide may be used for other purposes not listed in this medication guide.
What are the possible side effects of procainamide injection (Procan Sr)?
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have a serious side effect such as:
- a new or a worsening irregular heartbeat pattern;
- chest pain, wheezing, trouble breathing;
- feeling like you might pass out;
- signs of infection such as fever, chills, sore throat, flu symptoms, easy bruising or bleeding (nosebleeds, bleeding gums), loss of appetite, nausea and vomiting, mouth sores, unusual weakness;
- depressed mood, hallucinations, severe dizziness;
- stomach pain, nausea, vomiting, loss of appetite, dark urine, jaundice (yellowing of the skin or eyes); or
- joint pain or swelling with fever, swollen glands, muscle pain or weakness, unusual thoughts or behavior, patchy skin color, red spots.
Less serious side effects may include:
- mild dizziness or tired feeling;
- upset stomach, diarrhea; or
- mild itching.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What is the most important information I should know about procainamide injection (Procan Sr)?
Procainamide is given in a hospital setting. Your heart rate, breathing, blood pressure and other vital signs will be watched closely while you are receiving procainamide.
You should not use this medication if you are allergic to procainamide, or if you have certain heart conditions, especially "AV block" (unless you have a pacemaker), lupus, or a history of "Long QT syndrome."
If possible, before you receive procainamide, tell your doctor if you have congestive heart failure, circulation problems, a history of heart attack or stroke (including "mini-stroke"), a weak immune system, kidney or liver disease, myasthenia gravis, asthma, or if you are allergic to aspirin, sulfites, or any type of numbing medicine.
In an emergency situation, it may not be possible before you are treated to tell your caregivers about any health conditions you have or if you are pregnant or breast-feeding. However, make sure any doctor caring for you afterward knows that you have received this medication.
Procainamide can lower blood cells that help your body fight infections. Tell your doctor if you develop signs of infection such as fever, chills, sore throat, flu symptoms, easy bruising or bleeding (nosebleeds, bleeding gums), loss of appetite, nausea and vomiting, mouth sores, or unusual weakness.
- Pronestyl
- Procan Sr
No comments:
Post a Comment